medical Class II Updated 2024-01-24

Smiths Medical Asd Inc recalls Medex LOGICAL CATH LAB KIT, List Number M20754

Recalled Product

Medex LOGICAL CATH LAB KIT, List Number M20754


Hazard / Issue

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 10351688510686; Lot Number: 4371054
View official government recall

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